Duns Number:688322841
Device Description: Meta Clip-P Applier Plus are indicated for use as delivery or remover devices for the clip Meta Clip-P Applier Plus are indicated for use as delivery or remover devices for the clips of Meta Biomed Co., Ltd. Both applier and remover are made of stainless steel.
Catalog Number
-
Brand Name
Meta Clip-P Applier Plus(ERAPMLA)
Version/Model Number
9566
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GDO
Product Code Name
Applier, Surgical, Clip
Public Device Record Key
8eb3d339-bb80-4596-8582-1a96438266e4
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 24, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |